FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
JACE MODEL T300 TOE CPM DEVICE
K Number: K913227
·
Decision Aug 16, 1991
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
159
Applicant Total
3
Review Days
25
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Basic Information
- Device Name
- JACE MODEL T300 TOE CPM DEVICE
- K Number
- K913227
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thera Kinetics, Inc.
- Date Received
- July 22, 1991
- Decision Date
- August 16, 1991
- Product Code
- BXB
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BXB | Exerciser, Powered | FDA class 1 | Physical Medicine |
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